Label: VIABECLINE- tetracycline hydrochloride ointment

  • NDC Code(s): 71491-100-00, 71491-100-01
  • Packager: Accuria, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 24, 2017

If you are a consumer or patient please visit this version.

  • Activer Ingredient (in each gram)

    Tetracycline Hydrochloride 30 mg

    Close
  • Purpose

    First Aid Antibiotic

    Close
  • Use

    First aid to help prevent skin infection in minor cuts, scrapes, and burns.

    Close
  • Warnings

    For external use only. May be harmful if swallowed.

    Allergy Alert: Do not use if allergic to any ingredient listed on this label.

    Do not use

    • in the eyes
    • over large areas of the body
    • longer than 1 week unless directed by a doctor

    Ask  doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if the condition persists or gets worse.

    Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. ‚ÄčIf swallowed, get medical help or contact a poison Control Center right away.

    Close
  • Directions

    • Clean the affected area
    • Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily.
    • May be covered with a sterile bandage.
    Close
  • Other information

    • Keep product refrigerated to preserve its effectiveness and color
    • Stop use if the product is misused: If the bottle is left open and or not refrigerated, the liquid will tend to turn black over time. Discard the product if the liquid turns black due to misuse.
    • This product is an OTC antibiotic for human use.
    • Contains no alcohol, no animal ingredients.
    • Blended for typical skin color.
    • May stain cloth.
    • No claims regarding stem cell healing are implied for this product.
    Close
  • Inactive Ingredients

    ACETIC ACID, ASCORBIC ACID, CHLORHEXIDINE GLUCONATE, CHOLECALCIFEROL, DIMETHYL SULFOXIDE, DIPROPYLENE GLYCOL, GLUCONO DELTA LACTONE, GLYCERIN, HISTIDINE, HYDROXETHYL-CELLULOSE, MAGNESIUM STEARATE, METHYLPARABEN, SODIUM HYDROXIDE, SORBIC ACID, STEARIC ACID, WATER

    Close
  • Package Label: 71491-100-00 VIABECLICNE 5 ML Package Label: 71491-100-01 VIABECLINE 15ML
  • INGREDIENTS AND APPEARANCE
    VIABECLINE 
    tetracycline hydrochloride ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71491-100
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T) TETRACYCLINE HYDROCHLORIDE 30 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ACETIC ACID (UNII: Q40Q9N063P)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HISTIDINE (UNII: 4QD397987E)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71491-100-01 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 06/15/2017
    2 NDC:71491-100-00 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 06/15/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 06/14/2017
    Labeler - Accuria, LLC (080520669)
    Establishment
    Name Address ID/FEI Business Operations
    Filltech USA, LLC 965596435 manufacture(71491-100)
    Close